Health Canada: Regulatory Enrolment Process (REP)

As of October 1st, 2020, the use of the Regulatory Enrolment Process (REP) is mandatory for pharmaceutical, biologic and radiopharmaceutical drugs for human use in Canada.

As of October 1st, 2020, the use of the Regulatory Enrolment Process (REP) is mandatory for pharmaceutical, biologic and radiopharmaceutical drugs for human use in Canada.
June 15, 2021

✦As of October 1st, 2020, the use of the Regulatory Enrolment Process (REP) is mandatory for pharmaceutical, biologic and radiopharmaceutical drugs for human use in Canada.

✦Starting today, Extedo® and Asphalion launch a monthly infographic to resume updates in terms of publishing and eSubmission at a regional level. This month we are starting with Canada!

ASPHALION and our partner Extedo® can offer you a wide range in Regulatory Services and Solutions in Canada. Asphalion can guide you with the transition to REP and with all the REP templates (RT, PI and CO) to be filed for each submission thereafter.

✦Stay tuned for the next updates!

✦Download the document with the flow chart here:

Health-Canada-Asphalion-Extedo

✦For further information, you can contact us at: info@asphalion.com

 

 

 

Search News & Events

  • Filter by category

Share

Related news and events

RBDCOV | 14-months follow-up meeting

The second face-to-face RBDCOV meeting is taking place today at Palau Macaya in Barcelona! Our expert, Chris Mann, is attending the meeting in person. After

2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) – often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting